Download Non-small cell lung cancer, advanced or metastatic, in combin

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COMPENDIA TRANSPARENCY TRACKING FORM
DRUG:
Thalidomide
INDICATION:
Non-small cell lung cancer, advanced or metastatic, in combination with a platinum-based regimen
COMPENDIA TRANSPARENCY REQUIREMENTS
1
Provide criteria used to evaluate/prioritize the request (therapy)
2
Disclose evidentiary materials reviewed or considered
3
Provide names of individuals who have substantively participated in the review or disposition of the request and disclose their potential
direct or indirect conflicts of interest
4
Provide meeting minutes and records of votes for disposition of the request (therapy)
EVALUATION/PRIORITIZATION CRITERIA:
C, E, S
*to meet requirement 1
CODE
A
C
E
L
P
R
S
EVALUATION/PRIORITIZATION CRITERIA
Treatment represents an established standard of care or significant advance over current therapies
Cancer or cancer-related condition
Quantity and robustness of evidence for use support consideration
Limited alternative therapies exist for condition of interest
Pediatric condition
Rare disease
Serious, life-threatening condition
Note: a combination of codes may be applied to fully reflect points of consideration [eg, therapy may represent an advance in the treatment of a lifethreatening condition with limited treatment alternatives (ASL)]
©2012 Truven Health Analytics Inc. All rights reserved.
Jan_2013 [1084]
Page 1 of 5
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EVIDENCE CONSIDERED:
*to meet requirements 2 and 4
CITATION
Lee,S.M., Rudd,R., Woll,P.J., et al:
Randomized double-blind placebocontrolled trial of thalidomide in
combination with gemcitabine and
Carboplatin in advanced non-small-cell
lung cancer. J Clin Oncol Nov 01, 2009;
Vol 27, Issue 31; pp. 5248-5254.
Hoang,T., Dahlberg,S.E., Schiller,J.H.,
et al: Randomized phase III study of
thoracic radiation in combination with
paclitaxel and carboplatin with or
without thalidomide in patients with
stage III non-small-cell lung cancer: the
ECOG 3598 study. J Clin Oncol Feb
20, 2012; Vol 30, Issue 6; pp. 616-622.
Jazieh,A.R., Komrokji,R., Gupta,A., et
al: Phase II trial of thalidomide,
irinotecan and gemcitabine in
chemonaive patients with advanced
non-small cell lung cancer. Cancer
Invest Nov 2009; Vol 27, Issue 9; pp.
932-936.
Miller,A.A., Case,D., Atkins,J.N., et al:
Phase II study of carboplatin,
irinotecan, and thalidomide in patients
with advanced non-small cell lung
cancer. Journal of Thoracic Oncology:
Official Publication of the International
Association for the Study of Lung
Cancer Oct 2006; Vol 1, Issue 8; pp.
832-836.
STUDY-SPECIFIC COMMENTS
LITERATURE
CODE
Study methodology comments:
Key bias criteria evaluated were (1) random sequence generation of randomization; (2) lack of
allocation concealment, (3) lack of blinding, (4) incomplete accounting of patients and outcome
events, and (5) selective outcome reporting bias. The study was at low risk of bias for these key
criteria, except for random sequence generation. The authors did not provide any information on this
criterion so the risk of bias could not be determined.
Study methodology comments:
This was an open-label randomized trial. Overall, this study was at low risk for most of the key risk of
bias criteria which included lack of blinding, incomplete accounting of patients and outcome events,
and selective outcome reporting. The risk of bias associated with random sequence generation and
allocation concealment was unclear and not discussed in the paper. It should be noted that in April
2007, at the third interim analysis of OS among eligible patients (73.9% information), the data
monitoring committee recommended stopping the trial for futility because the 95% repeated CI for the
OS HR was 0.81 to 1.34.
©2012 Truven Health Analytics Inc. All rights reserved.
S
S
3
3
Jan_2013 [1084]
Page 2 of 5
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Dudek,A.Z., Lesniewski-Kmak,K.,
Maddaus,M., et al: Phase II trial of
neoadjuvant therapy with carboplatin,
3
gemcitabine plus thalidomide for stage
IIB and IIIA non-small cell lung cancer
(NSCLC). Annals of Oncology 2007;
Vol 18, pp. 184-184.
Flora,D.B., Kleykamp,B., Knapp,M., et
al: A phase II trial of thalidomide (T),
irinotecan (I) and gemcitabine (G) in
chemonaive patients (pts) with
3
advanced non-small cell lung cancer
(NSCLC). Journal of Clinical Oncology
Jul 15, 2004; Vol 22, Issue 14; pp.
680S-680S.
Seidler,C.W., Rooney,J., Kodali,D., et
al: A phase I/II trial of docetaxel and
daily thalidomide in patients with
previously treated recurrent non-small
cell lung cancer. Journal of Clinical
Oncology Jul 15, 2004; Vol 22, Issue
14; pp. 686S-686S.
Literature evaluation codes: S = Literature selected; 1 = Literature rejected = Topic not suitable for scope of content; 2 = Literature rejected = Does not
add clinically significant new information; 3 = Literature rejected = Methodology flawed/Methodology limited and unacceptable; 4 = Other (review
article, letter, commentary, or editorial)
©2012 Truven Health Analytics Inc. All rights reserved.
Jan_2013 [1084]
Page 3 of 5
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CONTRIBUTORS:
*to meet requirement 3
PACKET PREPARATION
DISCLOSURES
EXPERT REVIEW
DISCLOSURES
Margi Schiefelbein, PA
Stacy LaClaire, PharmD
Felicia Gelsey, MS
None
None
None
Edward P. Balaban, DO
James E. Liebmann, MD
Keith A. Thompson, MD
Jeffrey A. Bubis, DO
Gerald J. Robbins, MD
None
None
None
Other payments; Dendreon
None
ASSIGNMENT OF RATINGS:
*to meet requirement 4
MICROMEDEX
Edward P. Balaban, DO
James E. Liebmann, MD
Keith A. Thompson, MD
Jeffrey A. Bubis, DO
EFFICACY
STRENGTH OF
RECOMMENDATION
--Ineffective
--Class III - Not Recommended
Ineffective
Ineffective
Ineffective
©2012 Truven Health Analytics Inc. All rights reserved.
Class III - Not Recommended
Class III - Not Recommended
Class III - Not Recommended
Jan_2013 [1084]
COMMENTS
STRENGTH OF
EVIDENCE
B
Although the clinical studies have some
inherent flaws, the addition of
thalidomide to combination
chemotherapy for non-small cell lung
cancer has done little to improve
treatment or outcome.
The two large, well-conducted phase lll
trials reviewed show no benefit from
thalidomide in the treatment of stage lll
or lV NSCLC. Instead, thalidomide
caused toxicity. There is no justification
for the use of thalidomide in non-small
cell lung cancer.
None
There is no data that supports an
outcome benefit in this setting.
N/A
N/A
N/A
N/A
Page 4 of 5
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Gerald J. Robbins, MD
Ineffective
©2012 Truven Health Analytics Inc. All rights reserved.
Class III - Not Recommended
Jan_2013 [1084]
Although some bias may exist, it would
be unlikely in these 2 large, randomized
phase lll trials in both squamous and
non-squamous histologies and 2
different chemotherapy protocol based
trials.
N/A
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